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Use caution Drug recall · FDA · Published October 19, 2015

Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Risk

Western Drug recalls all lots of Hydroxocobalamin 5000IU/mL Injection due to lack of assurance of sterility. Nationwide distribution.

🇺🇸 FDA recall #D-0410-2016DrugWestern Drug ›
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Recalling firmWestern Drug105 W Main St · Springerville, AZ 85938-7203
✎ GovInfoNow plain-language explainer

What happened, in plain English

Western Drug has recalled all lots of its Hydroxocobalamin 5000IU/mL Injection because there is a lack of assurance of sterility. This Class II recall affects products distributed nationwide across several states including Arizona, California, and Texas. The record does not specify the exact remedy or deadline for this recall. Read more at govinfonow.com/recall/43426-western-drug-recalls-hydroxocobalamin-5000iu-ml-injection-rx-western-drug.

Source Summary by GovInfoNow · govinfonow.com/recall/43426-western-drug-recalls-hydroxocobalamin-5000iu-ml-injection-rx-western-drug · Updated October 11, 2026 · FDA enforcement record: FDA #D-0410-2016

Cite this page

“Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43426-western-drug-recalls-hydroxocobalamin-5000iu-ml-injection-rx-western-drug. Based on FDA recall #D-0410-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0410-2016%22&limit=1).

Why it’s dangerous

The product lacks assurance of sterility, which means it may be contaminated with microorganisms. Injecting a non-sterile product can lead to serious infections or other complications at the injection site or systemically.

Who’s affected

Patients who have received or possess Hydroxocobalamin 5000IU/mL Injection from Western Drug Inc., particularly those in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.

How to tell if you have this one

Look for Hydroxocobalamin 5000IU/mL Injection manufactured by Western Drug Inc., located at 106 E. Main Street, Springerville, Arizona 85938. The recall covers all lots of this product.

  • Brand
    Western Drug
  • Category
    Drug
FDA recall event · 91 products

All 91 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
Recall numberProduct, codes & lotsQuantity
D-0394-2016Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots16 containers
D-0395-2016Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0396-2016AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0397-2016B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0398-2016Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0399-2016Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0400-2016Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0401-2016Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0402-2016Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots9 containers
D-0403-2016Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0404-2016Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots8 containers
D-0405-2016Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0406-2016Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0407-2016Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0408-2016Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0409-2016Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0410-2016Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0411-2016M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0412-2016M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0413-2016Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots17 containers
D-0414-2016Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots46 containers
D-0415-2016Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots34 containers
D-0416-2016Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 conatiners
D-0417-2016Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0418-2016Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots6 containers
D-0419-2016Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0420-2016Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0421-2016Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0422-2016Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0423-2016Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0424-2016Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0425-2016Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots5 containers
D-0426-2016Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0427-2016Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0428-2016HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona; all lots8 container
D-0429-2016Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0430-2016Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0431-2016Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0432-2016Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0433-2016Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0434-2016Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0435-2016Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0436-2016Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0437-2016Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots5 containers
D-0438-2016N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0439-2016Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 vial
D-0440-2016Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots18 containers
D-0441-2016Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0442-2016Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0443-2016Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0444-2016Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0445-2016Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0446-2016Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0447-2016PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots9 containers
D-0448-2016Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots15 containers
D-0449-2016Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0450-2016Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots45 containers
D-0451-2016Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0452-2016Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0453-2016Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0454-2016Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots15 containers
D-0455-2016T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0456-2016Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0457-2016Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots75 containers
D-0458-2016Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0459-2016Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots39 containers
D-0460-2016Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots6 containers
D-0461-2016Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0462-2016Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0463-2016Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots36 containers
D-0464-2016Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots68 containers
D-0465-2016Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0466-2016Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0467-2016Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots8 containers
D-0468-2016Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots7 containers
D-0469-2016VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0470-2016Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0471-2016Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0472-201617-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots41 containers
D-0473-2016Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0474-2016Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0475-2016HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 vials
D-0476-2016Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0477-2016Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0478-2016Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots4 containers
D-0479-2016Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots3 containers
D-0480-2016Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots2 containers
D-0481-2016Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots16 containers
D-0482-2016Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0483-2016Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
D-0484-2016Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938; all lots1 container
Based on the official FDA remedy

What to do — step by step

  1. Check Your Inventory

    Verify if you have Hydroxocobalamin 5000IU/mL Injection from Western Drug Inc., as all lots are included in this recall.

  2. Consult Healthcare Provider

    Contact your healthcare provider or pharmacist for guidance on what to do with the recalled product, as the specific remedy is not stated in the record.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, Utah.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Oct 19, 201512. FDA classified it Class II: Dec 1, 201523. Published in FDA’s Enforcement Report: Dec 9, 201534. FDA terminated the recall: Oct 1, 2016420152016
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0410-2016 (October 19, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0410-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA